CGM in Acute Ischemic Stroke

Официальное название

Continuous Glucose Monitoring for Enhanced Management of Hyperglycemia in Persons With Type 2 Diabetes Undergoing Endovascular Therapy for Acute Ischemic Stroke: a Randomized Controlled Trial.

Обзор

The goal of this randomized clinical trial is to evaluate whether continuous glucose monitoring (CGM) can be used to guide glucose management in patients with type 2 diabetes who are admitted with an acute ischemic stroke and undergo endovascular therapy. Hyperglycemia frequently occurs during hospitalization in stroke and is associated with worse neurological and clinical outcomes. In current clinical practice, glucose levels are monitored using intermittent point-of-care testing (POCT) with finger-prick measurements, which may miss clinically relevant glucose fluctuations. CGM provides continuous glucose measurements and may allow earlier detection of hyperglycemia and more timely glucose management. This study is designed as a non-inferiority randomized controlled trial comparing CGM-guided glucose management with standard POCT-guided glucose management. The primary objective is to determine whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (glucose \>10 mmol/L) during the first 72 hours of hospitalization. Researchers will compare CGM-guided glucose management to POCT-guided glucose management to evaluate whether CGM can be used as an alternative strategy to guide glucose control in hospitalized stroke patients. Participants will: * Be randomly assigned to either CGM-guided glucose management or standard POCT-guided glucose management * Have their glucose levels continuously monitored (blinded in the POCT-guided group) during hospitalization * Receive glucose management according to the assigned monitoring strategy, based on the hospital insulin protocol

Вмешательства

• Устройство Continuous Glucose Monitoring
  Continuous glucose monitoring using the FreeStyle Libre systems (Abbott Diabetes Care) to measure interstitial glucose levels through a subcutaneous sensor that continuously records glucose concentrations during hospitalization.
• Диагностический тест Point-of-Care Testing
  Intermittent glucose monitoring using point-of-care finger-prick capillary blood glucose measurements according to the hospital glucose management protocol.

Первичные конечные точки

• Time spent in hyperglycemia (>10 mmol/L) [Срок оценки: During the first 72 hours of hospitalization]

Вторичные конечные точки (9)

• Duration of hyperlgycemic episodes (>10 mmol/L) [Срок оценки: During the first 72 hours of hospitalization]
• Duration of hypoglycemic episodes (<3.9 mmol/L) [Срок оценки: During the first 72 hours of hospitalization]
• Time in normoglycemia (3.9-10.0 mmol/L) [Срок оценки: During the first 72 hours of hospitalization]
• Time in hypoglycemia (<3.9 mmol/L) [Срок оценки: During the first 72 hours of hospitalization]
• In-hospital complications [Срок оценки: During the first 72 hours of hospitalization]
• Neurological recovery [Срок оценки: Baseline to 24 hours post-EVT]
• Good functional outcome [Срок оценки: 3 months post stroke]
• Health-related quality of life [Срок оценки: 3 months post stroke]
• All-cause mortality [Срок оценки: 3 months post stroke]

Критерии участия

Критерии включения

• Age ≥18 years
• Acute ischemic stroke treated with endovascular therapy (EVT)
• Type 2 diabetes mellitus, defined as one of the following:
• documented diagnosis of type 2 diabetes mellitus
• use of glucose-lowering medication
• admission plasma glucose ≥11.1 mmol/L
• HbA1c ≥48 mmol/mol (≥6.5%)

Критерии исключения

• Current pregnancy
• Extensive skin infections or dermatological conditions at the intended sensor site
• Medical situations known to interfere with CGM accuracy, including:
• Hypotension defined as a systolic blood pressure <100 mmHg at 30 and 60 minutes after admission
• Dialysis treatment
• Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m²
• Use of medications known to interfere with CGM accuracy, including:
• Acetaminophen >4 g/day
• Dopamine
• High-dose vitamin C (ascorbic acid)
• Hydroxyurea / hydroxycarbamide
• Clinically relevant pancreatic disease
• Systemic glucocorticoid therapy with a prednisone-equivalent dose >5 mg/day
• Expected admission to an intensive care unit (ICU)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07510919 · NL009652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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